Compliance Specialist

Job description

Job Description

Requisition ID: 4922180625

The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting a Compliance Specialist located in Irving, TX.

The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster (BWI), Mentor, Neurovascular and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Neurovascular and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.

Mentor is a trusted global leader in aesthetic medicine among both consumers and clinicians by providing a broad range of innovative, science and clinical-based solutions to maintain, enhance, and restore self-esteem and quality of life. The company has products and services in three areas of aesthetics: breast (augmentation and reconstruction), body and face.

The Compliance Specialist will coordinate the various compliance activities by performing site inspection preparedness and identifying risks, conducting internal audits, participating in improvement initiatives, and suggesting process changes when appropriate. This individual will coordinate Compliance activities, the Internal Audit program and/or other quality compliance elements, as assigned. Perform internal audits to determine compliance with Quality Management System standards, policies and procedures, as well as regulatory and customer requirements. This includes assistance with conducting audits, generating reports with corrective action plans and ensuring implementation of corrective actions in a timely fashion.

Additional Responsibilities:

• S/he will coordinate the Internal Audit schedule, supports internal and external audits, monitors execution and ensures timely completion of observation response and action items.
• Coordinate internal and external audit preparation, assists during audits for front/back room support and ensures follow-up after audits including coordination of corrective actions for observations.
• Investigates and develops solutions to procedure and process related issues.
• Participates on project teams to improve processes at either a local or global level. May lead project teams.
• Assists in the execution and distribution of standard metric ad hoc reports, preparation of compliance input for management reviews, maintains company Compliance Scorecard and related documentation.
• Assist in determining root causes of Quality issues and develop corrective actions and recommendations.
• Assist in establishing, maintaining and implementing communications to increase compliance awareness and promote improvement of the compliance profile across the business.
• Prepare basic trend analysis on identified key performance indicators.
• Use basic statistical methods, Quality tools and computer-generated reports to improve processes where appropriate.
• S/he will provide support in the establishment and maintenance of processes to ensure regulatory requirements for compliance are met.
• Ensure the Quality Management System is maintained in a state of readiness to applicable regulations and directives such as 21CFR820, ISO 13485, Medical Device Directive (MDD), Canadian Medical Device Regulation (CMDR), Therapeutic Goods Administration (TGA) - Australia, National Health Surveillance Agency (ANVISA) - Brazil, Ministry of Health, Labor and Welfare (MHLW) - Japan, applicable regulatory requirements and Johnson & Johnson corporate standards as applicable.
• Prepare/coordinate regulatory assessments following established procedures; prepare appropriate reports of audit findings to auditees and management representatives; review and monitor required corrective actions.
• Provide support for FDA and other governmental or ISO Notified Body inspections, including pre- and post-inspection support, as requested; conduct support activities with front/back room support, and assisting with corrective action and/or remediation plans, as necessary; consult with management and cross functional partners to help formulate and implement proactive regulatory compliance strategies and controls.
• Collaborate with business partners to ensure compliance to all regulatory and standard requirements.
• The individual will monitor all sources of quality data to ensure appropriate review and escalation through the risk management system in efficient and timely manner.
• Responsible for coordinating cross functional teams and relevant metrics reporting to ensure compliance with defined procedures.
• Responsible to provide support/backup to the Compliance Manager.

Desired profile

Qualifications

• A minimum of a Bachelor’s degree is required, preferably in Science or Engineering.
• A minimum of two (2) years of experience in a medical device, pharmaceutical or GMP environment is required.
• A minimum of one (1) year of experience coordinating compliance and/or quality system activities is required.
• The ability to interpret compliance regulations, requirements and effectively apply them to the implementation and/or enhancement of quality systems is required.
• Knowledge of the following regulatory requirements (Quality System Regulations (QSRs), Good Manufacturing Practices (GMPs), 21CFR820, ISO 13485, Medical Device Directive (MDD), Canadian Medical Device Regulation (CMDR), Therapeutic Goods Administration (TGA) - Australia, National Health Surveillance Agency, (ANVISA) - Brazil, Ministry of Health, Labor and Welfare (MHLW) – Japan) is preferred.
• Experience supporting external audits (such as FDA, Notified Body, or customer audits) is required.
• Demonstrated knowledge of audit principles, concepts and practices related to a regulated quality system is required.
• The ability to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies is preferred.
• Proficiency with Microsoft Toolset (Microsoft Word, Excel, and PowerPoint) is required.
• An ASQ certification (CQE, CQM, CRE or CQA), Six Sigma (Green Belt, Black Belt) or Process Excellence certification is preferred.
• Prior project management experience is preferred.
• Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment is preferred.
• Prior experience effectively working through periods of change, ambiguity and complexity is preferred
• Experience thriving in a collaborate work environment is preferred.
• Computer system validation experience is preferred.
• This position is located in Irving, TX and may require up to 10% (international and domestic) travel.

Primary Location
United States-Texas-Irving
Organization
Mentor Texas LP (6182)
Job Function
Compliance
Requisition ID
4922180625